[Trial of device that is not approved or cleared by the U.S. FDA]

An On-body Injector is a small device, which is adhered to the skin with a sticky patch. The injector is intended to deliver a small volume of medicine from a reservoir inside the device into the skin via a small catheter. The drug delivery happens after a period of time, as programmed into the device, and afterwards the device can be removed.

The purpose of this study is to evaluate how well the BD Evolve™ On-body Injector adhesive pad sticks to the skin and how the adhesive keeps the device in position when worn on the arm during normal daily activities for 28 hours. As this study only evaluates the performance of the adhesive pad of the OBI, no injection will be performed, and the device will not be filled with any fluid. The injection capability will be disabled.

Study Overview

• Status: Withheld
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: Device wear on skin

Detailed Description

The BD Evolve™ On-body Injector (OBI) is being developed as a platform drug delivery device for use with a class or family of drug products approved for subcutaneous injections. It is a small, fill-at-use device based on a core BD technology for wearable pump drug delivery systems.

The OBI is a sterile, single-use, single-dose, disposable wearable pump injector that delivers a fixed dose of 0.6ml of drug approximately 27 hours after the device is activated; the dose will be delivered subcutaneously over a duration of 35 minutes in the home environment.

The purpose of this study is to assess the adherence performances (adhesive pad to participants' skin and heat stake) of the BD Evolve™ On-body injector (OBI) when worn on the arm for 28 hours, under normal daily activities in generally healthy human subjects, with and without use of an additional adhesive ring. Cutaneous tissue effects associated with wear of the OBI device, with and without use of an additional adhesive ring, will also be assessed.

• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Fair Lawn, New Jersey, United States, 07410
      • TKL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy male or female participants ≥ 18 years of age, at the time of signing the informed consent, without evidence of acute illness.
2. Participant with a BMI ≥18.5 kg/m2.
3. Participant able to read, write, and understand English.
4. Participant willing and able to complete all required study procedures.
5. Participant willing and able to wear a loose-fitting, short sleeved shirt during each of the two study visits.
6. Participant willing to have hair clipped at the application site if deemed necessary by the investigator.
7. Provision of signed and dated informed consent form.

Exclusion Criteria:

1. Participants who have applied lotions, creams, oils, or similar products to the arm on study days.
2. Participants who are pregnant or breast-feeding (self-reported).
3. Participants with any self-reported uncontrolled chronic illness (heart disease, respiratory disease, kidney disease, metabolic diseases etc.).
4. Participants with treatment interfering with the coagulation system (e.g. anticoagulants), agents decreasing platelet function (e.g. aspirin) or reducing platelet count (thrombocytopenia due to long-term usage of beta-lactam antibiotics and sulfamethoxazole), within 12 hours of and during an in-clinic visit.
5. Participants undergoing peeling, laser treatment or dermabrasion on the arms.
6. Participants who have tattoos, skin issues or infection at the application sites, including, but not limited to ulceration, blister, inflammation, extensive scarring or callous, swelling or healed burns (to be verified by study HCP).
7. Participants with current visible skin disease, inflammation or infection (e.g. acne, herpes), hyperkeratosis (e.g. psoriasis, chronic eczema) on the arm and/or redundant skin (e.g. participants with significant weight loss).
8. Participants with any history of skin sensitivity, including reactions to adhesive such as those in skin bandages or skin tape (particularly acrylic adhesive).
9. Participants who have a known latex allergy.
10. Participants not willing to shave long hairs from their arm before application.
11. Participants who are unwilling to be photographed as required by the study.
12. Participants suspected to have non-compliance with the study procedures and/or of non-completion of the study according to the investigator's judgment.
13. Participants with evidence of current abuse of drugs or alcohol or a history of abuse that, in the investigator's opinion, would cause the individual to be noncompliant.
14. Participants under administrative or legal supervision.

Study Plan

How is the study designed?

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 - On-body Injector (OBI) - only; Adhesion of device with adhesive on left or right upper arm	Device: Device wear on skin; Participant will wear the device over a period of 28 hours to assess adhesive performance and potential skin effects.
Experimental: Arm 2 - OBI + additional adhesive ring; Adhesion of device with adhesive on left or right upper arm + additional adhesive ring to be placed additional on the skin.	Device: Device wear on skin; Participant will wear the device over a period of 28 hours to assess adhesive performance and potential skin effects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence Performance	To assess the adherence performance of the OBI device on the arm over 28 hours of wear under normal daily activities in generally healthy human subjects, with and without use of an additional adhesive ring. Primary Endpoint: Adhesive integrity at the end of device wear: adhesive pad adherence to participants' skin,- Adherence integrity and performance will be assessed by: - Change in adhesive pad adherence - device to skin via an adherence scale: Score 0-4, whereby 0 is full adherence and 4 is reflecting full detachment.	During wear period of 28 hours
Adherence Performance	To assess the adherence performance of the OBI device on the arm over 28 hours of wear under normal daily activities in generally healthy human subjects, with and without use of an additional adhesive ring. Primary Endpoint: heat stake adherence (device body to adhesive pad). Adherence integrity and performance will be assessed by: - Change in heat stake adherence - device body to adhesive pad via a 3-point scale: fully adhered, partially adhered, not adhered.	During wear period of 28 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin effects	To assess cutaneous tissue effects associated with wear of the OBI device, with and without use of an additional adhesive ring. Secondary endpoint: Skin assessments for the presence of erythema, wheal, bleeding, bruising, and induration following device removal (if applicable), utilizing specific tissue effects scales. Assessment of wheal, erythema and bleeding will be described via grading, whereby 0 is the absence of event and 4 is reflecting most severe presence of event. Bruising and induration will be reported as being present or not (yes/no)	Upon device removal and at 30 min, 2 hours after device removal

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Adverse device effects	To assess adverse events. Endpoint: Record adverse events related to the device effects and/or procedure related adverse events.	Starting at timepoint of enrollment up to 2 hours after device removal.

Collaborators and Investigators

• Sponsor: [Redacted]
• Investigators: Principal Investigator: Jesson Yeh, MD, TKL Research, Inc.

Study record dates

Study Major Dates

• Study Start: February 14, 2024
• Primary Completion: March 6, 2024
• Study Completion: March 6, 2024

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PHS-23OBI03

Plan for Individual participant data (IPD)

• IPD Plan Description: This is a study related for product development.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes